MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CODMAN PERFORATOR; PERFORATOR, 14MM

Model Number 26-1221

Device Problems Protective Measures Problem (3015); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/08/2021

Event Type  Injury  

Event Description

Pt scheduled for stage 1 deep brain stimulation (dbs) procedure on (b)(6) 2021.During the drilling of the burr hole, the perforator attachment connected to the medtronic midas rex mr8 drill malfunctioned and did not stop after drilling the bone causing the attachment to go through the patient's dura.Surgical staff chose to abort the dbs procedure.Another physician was called in to assist in a craniotomy where the bleeding was stopped, a metal plate was placed, and the incision was stapled closed and dressed.Patient was then stable.

Event Description

Pt scheduled for stage 1 deep brain stimulation (dbs) procedure on (b)(6) 2021.During the drilling of the burr hole, the perforator attachment connected to the medtronic midas rex mr8 drill malfunctioned and did not stop after drilling the bone causing the attachment to go through the patient's dura.Surgical staff chose to abort the dbs procedure.Another physician was called in to assist in a craniotomy where the bleeding was stopped, a metal plate was placed, and the incision was stapled closed and dressed.Patient was then stable.

• Brand Name: CODMAN PERFORATOR
• Type of Device: PERFORATOR, 14MM
• Manufacturer (Section D): INTEGRA LIFESCIENCES; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 13585619
• MDR Text Key: 286044706
• Report Number: 13585619
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Device Lot Number: 5502449
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2022
• Distributor Facility Aware Date: 12/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American